MAUDE Adverse Event Report: ALIGN TECHNOLOGY INVISALIGN; ORTHODONIC ALIGNER

Health Effect - Clinical Codes	Burning Sensation (2146); Sore Throat (2396)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Have been using invisalign for 2 days.Have severe sore throat and throat burning.

• Brand Name: INVISALIGN
• Common Device Name: ORTHODONIC ALIGNER
• Manufacturer (Section D): ALIGN TECHNOLOGY
• MDR Report Key: 6321741
• Report Number: MW5067806
• Device Sequence Number: 694983
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARICEPT; IBUPROFEN. ; RX MEDS: ADDERALL; XYREM
• Patient Age: 34 YR
• Patient Weight: 48